Vaginal Repair of Symptomatic Postcesarean Isthmocele: Evaluating A Simple Novel Technique
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- myometrial thickness in supracervical area
研究概览
简要总结
20 WOMEN WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE (NICHE) WILL BE RECRUITED EVALUATED AND SUBJECTED TO A VAGINAL REPAIR OF THE DEFECT, RESULTS WILL BE ANALYZED.
详细描述
METHODS:
- Subjects: women in childbearing period with abnormal uterine bleeding or infertility attributed to post cesarean isthmocele (sample size to be calculated)
- Preoperative evaluation: transvaginal ultrasound to exclude any other uterine or adnexal pathology, and to measure:
- Distance from the external cervical os to the lower end of the isthmocele (A)
- Distance from the external cervical os to the upper end of the isthmocele(B)
- Length of the isthmocele (B-A)
- Residual myometrial thickness (the least) of the isthmocele.
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Routine preoperative workup.
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The technique:
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Postmenstrual
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Spinal anesthesia
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Sterilization of the perineum and vagina
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Cervical dilation up to 8mm using Hegar's dilators
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Marking the previously measured points A & B
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Making 2 transverse incisions, one 5mm below A and the other 5 mm above B.
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The rectangular area between the 2 incisions is excised while the Hegar's dilator number 8 in in situ.
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Hemostasis is performed using diathermy.
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The upper and lower edges of the incision are approximated using number 2/0 vicryl on cutting needle taking 3 to 4 interrupted sutures
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The patients with uneventful postoperative course are discharged from hospital after 8 hours with doxycycline 100 mg bid for 5 days.
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Sexual intercourse is avoided for 4 weeks postoperative
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postoperative transvaginal ultrasound follow up; at 1 month postoperative.
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Data will be statistically analyzed and results will be tabulated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women diagnosed with symptomatic post cesarean isthmocele.
- •should present with abnormal uterine bleeding .
排除标准
- •presence of any other uterine pathology,
- •presence of adnexal pathology,
- •presence of malignancies,
- •presence of pregnancy,
- •presence of infection in the lower genital tract ,
- •general cause of bleeding
- •women not accepting the procedure,
- •women not consented
研究组 & 干预措施
women with symptomatic post cesarean Istmocele
vaginal surgical repair of post cesarean symptomatic isthmocele using conventional low cost surgical techniques
干预措施: vaginal surgical repair of isthmocele (Procedure)
结局指标
主要结局
myometrial thickness in supracervical area
时间窗: at 1 month postoperative
the myometrial thickness in the supracervical region is measured by transvaginal ultrasound postoperatively
次要结局
未报告次要终点
